Manufacturing

Human infections with avian flu strain H5N1 are occurring in a number of southeast Asian countries that have experienced large outbreaks of avian influenza. How great a risk to the human population is posed by this virus, and what steps can be taken to minimize its impact? Preventive vaccines have great potential to avert the spread of avian flu and other infectious diseases. What are the factors affecting the creation of new vaccines, and how can they be optimized to promote public health?

PAT can be defined as a collection of real-time data in-line to make decisions about product quality early in the production process.

The cell density achieved in a CELLine bioreactor is typically 1 to 2 orders of magnitude higher than in a conventional culture vessel

Operating costs are the white-hot issue in the boardrooms of our life sciences clients and they tend to rule the site selection process. A soft economy, worldwide trade competition, drug cost containment pressures from the US government, and a lean and mean message sent by the venture capital community mean that quantitative factors that focus on the cost of doing business are trumping qualitative lifestyle factors, especially when evaluating sites for a new biopharmaceutical facility.

...each day a product is delayed is estimated to cost upwards of $1 million to $100 million.

The methods used in most microbiological test laboratories originated in the laboratories of Koch, Lister, and Pasteur. While numerous changes have occurred in the chemistry laboratory, there have been limited improvements in methods used for microbiological testing.

A well-understood, validated, and correctly maintained BAS reduces the chance of a critical room parameter slipping out of specification.

As a company that performs site selection for biopharmaceutical companies worldwide, Fluor Global Location Strategies has witnessed one country truly distinguishing itself from the competition as a worldwide leader in the industry: the United Kingdom. The global competition for biotech investments has been at a fever pitch over the past few years, with varied results.

Scotland has a ready pool of skilled workers for companies seeking to conduct business in our country.

FDA plans to conduct good manufacturing practices (GMP) inspections of flu vaccine manufacturers annually instead of every two years.

As the fourth largest center for biotechnology and life sciences in the US, New Jersey is home to 15 of the world's 20 largest pharmaceutical companies. More than half of all new medicines approved in the US are developed by New Jersey companies. New Jersey is an ideal location because it offers close proximity to the financial markets in New York and Philadelphia, and a highly skilled workforce, strong funding, government support, and academic expertise.

Cell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.

Disposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination.

In a mere 30 years of development, a total of 23 MAbs and MAb-related proteins have been approved for medical treatments.

Your company's job is to make biopharmaceutical products. Managing facilities is a function supporting the main task. General manufacturing companies discovered this long ago, but pharmaceutical producers have been lagging. Once you consider the outsouring of non-core activities like facility management (FM), office services, space planning, and utilities management, you can focus on core business functions that make profits.

Three meetings of the BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, were held recently. The east coast meeting was hosted by Genzyme at its headquarters in Cambridge, MA; the west coast Chapter met at the Genentech campus in South San Francisco, CA; and the European forum held its meeting in Frankfurt, hosted by Aventis.

Conversion of facilities from one use to another is a positive trend that keeps good paying jobs in local communities.

Mass serialization, or the ability to store a unique serial number for each item, is the most useful feature of RFID tags.

Bioterrorism legislation is in the works, but there will be a tough fight to enact added liability protections for manufacturers.

Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration, clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming a reality.

In most production environments, it is critical to be able to associate historical environmental data with process data.

Unfortunately, once circuits are commissioned and validated, optimizing - or even adjusting - them is difficult and rarely done because of the time and effort required for revalidation.

Wyeth BioPharma has identified cycle-time reduction as critical to customer responsiveness and the success of commercial and pipeline products. In formulating a plan of attack, the company focused on two aspects of cycle time: the global planning process and disposition cycle times.

Identifying issues in the factory that traditionally arise in the field minimized onsite equipment rework and subsequent qualification work.

The objective of the feasibility stage is to determine whether the proposed biotechnological process can be executed.

It is not likely that you will ever personally design and build a cleanroom; however, you may be responsible for the care and upkeep of many.

Using disposable components for bioprocessing can reduce costs and complexity and may play an increasing role in large-scale biopharmaceutical manufacturing.

This article focuses on the front end of qualifying a new raw material from a given supplier. Once qualified, this status must be maintained by periodic review and requalification.

The biotechnology and pharmaceutical industries have some overriding concerns, namely regulatory and compliance issues, insufficient manufacturing capacity, and the economic challenges of producing niche drugs and therapies.

Biopharmaceutical manufacturers face many bioprocessing concerns including safety, flexibility, maintenance, capacity, capital investment, and process costs. Disposable products can reduce some of the burden.